UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009591 |
|---|---|
| Receipt number | R000011210 |
| Scientific Title | Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects |
| Date of disclosure of the study information | 2013/01/10 |
| Last modified on | 2014/06/10 09:10:37 |
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Basic information
Public title
Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects
Acronym
FMU-DF-001
Scientific Title
Clinical study of defibrotide in safety and pharmacokinetics in healthy adult subjects
Scientific Title:Acronym
FMU-DF-001
Region
| Japan |
Condition
Condition
Veno Occulisive Disease
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for safety and pharmacokinetics of defibrotide in Japanese healthy adult subjects.
Investigation for fibrinolytic and coagulation activity of defbrotide.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Presence of dose-limiting toxicities of 2 doses of defibrotide
Key secondary outcomes
Profile of adverse effects of defibrotide
Pharmacokinetics of defibrotide
Fibrinolytic and coagulation activit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
defibrotide
Interventions/Control_2
Placebo(physical saline)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male Japanese
2. >=20 years old and <=45 years old at voluntary written consent
3. >=50.0 kg and <100.0 kg, and >=18.5 and <25.0 of BMI at screening
4. No history of taken drugs within 6 days at screening
5. Clinical laboratory values are within normal levels in screening and before administration in hospital.
6. Normal in subjective and objective symptoms.
7. Voluntary written consent by themselves is given before screening and is reconfirmed after entering in hospital.
Key exclusion criteria
1. History of abnormal function in CNS, cardiovascular system, respiratory sytem, blood/hematopoietic system, gastroenteric system, liver/kidney, thyroid, pituitary gland, adrenal gland and so on and it is difficult to keep safety of subjects during clinical study.
2. Known hypersensitivity to some drugs
3. Abuse of alcohol or drugs
4. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
5. History of blood taken
*>=1200ml of all blood within 1 year before screening
*>=400ml of all blood with 84 days before screening
*>=200ml of all blood within 28 days before screening
*taken blood component within 14 days
*taken all blood or blood component after screening and before clinical laboratory tests at entering in hospital
6. Treatment with any investigational compound within 120 days before screening or after screening
7. Treatment by other doctors within 28 days before the dose of study drug
8. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Umemura |
Organization
Hamamatsu University Hospital
Division name
Center for clinical research
Zip code
Address
Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2006
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Umemura |
Organization
Hamamatsu University Hospital
Division name
Center for clinical research
Zip code
Address
Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2006
Homepage URL
http://www2.hama-med.ac.jp/w6a/trial/index.html
umemura@hama-med.ac.jp
Sponsor or person
Institute
Fukushima Medical University Clinical Oncology Center, Division of Pediatric Oncology, Atsushi Kikuta
Institute
Department
Personal name
Funding Source
Organization
ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
2012.11.20
Institutions
Institutions
浜松医大大学病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 20 | Day |
Last modified on
| 2014 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011210
